Drug Master Files for: FELBAMATE
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FELBAMATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 20438 | I | II | 4/12/2007 | APICORE US LLC | FELBAMATE |
| 21247 | A | II | 1/14/2008 | PROCOS SPA | FELBAMATE |
| 22201 | I | II | 11/20/2008 | HETERO DRUGS LTD | FELBAMATE |
| 22810 | A | II | 6/15/2009 | SOLARA A PHARMA SCIENCES LTD | FELBAMATE |
| 22958 | A | II | 7/15/2009 | APICORE US LLC | FELBAMATE USP |
| 27331 | A | II | 11/5/2013 | TARO PHARMACEUTICAL INDUSTRIES LTD | FELBAMATE USP |
| 28661 | A | II | 11/23/2015 | ENALTEC LABS PRIVATE LTD | FELBAMATE USP |
| >DMF No. | >Status | >Type | >Submission Date | >Holder | >Subject |
Drug Master File Glossary
STATUS OF DMFS
- A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
- I = Inactive
- N = Not an assigned number
- P = DMF Pending Filing Review
TYPES OF DMFs
- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
- Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
- Type III Packaging Material
- Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
- Type V FDA Accepted Reference Information
